Methodology evaluation of a kit for urine type Ⅳ collagen measurement and influence by pre-analytical factors
- VernacularTitle:尿Ⅳ型胶原测定的方法学评价及分析前因素对于测定的影响
- Author:
Xuejing WANG
;
Yoshihisa ITOH
- Publication Type:Journal Article
- Keywords:
urine;
pre-analytical factors;
collagen type Ⅳ;
enzyme-linked immunosorbent assay
- From:
Medical Journal of Chinese People's Liberation Army
2001;0(10):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective Urine type IV collagen has been recognized as an early sensitive marker for diabetic nephropathy. For quality assurance in clinical use, the function was initially evaluated as a one-step ELISA of sandwich method, and the reference intervals were established and the pre-analytical and influential factors were investigated. Methods ELISA was used to determine the concentration of type Ⅳ collagen in urine. Kit was evaluated on sensitivity, linearity, precision, specificity and recovery rate. Interference factors were also investigated, and a rough reference range was obtained. Pre-analytic factors, such as specimen collection, centrifugation, storage condition and duration, frozen and thawing, even diurnal periodicity, were all included in this test. Results The assay was satisfactory in sensitivity (0.2ng/ml), linearity (0.8-50ng/ml), precision (CV
